IMPORTANT SAFETY INFORMATIONWARNING:Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device.Continue below

Frequently Asked Questions About Essure®

Looking for more information about Essure? You’ve come to the right place.

Essure is permanent birth control that works with your body to prevent pregnancy. Already considering Essure? You might have questions about the Essure procedure or what permanent birth control could mean for you. Get some answers here. And, as always, talk to your doctor about any questions or concerns you may have.

About Essure

Essure is permanent birth control that works with your body to create a natural barrier against pregnancy. The procedure involves permanently placing a soft, flexible insert into each fallopian tube. Over a period of about 3 months, a natural barrier forms around the inserts which prevents sperm from reaching your eggs. During this time you must continue using another form of birth control to prevent pregnancy. Three months after your Essure procedure, you will need to have a Essure Confirmation Test to determine if you can rely on Essure for birth control. Your doctor will advise you on the type of test that is right for you.

IMPORTANT: YOU MUST SEE YOUR DOCTOR FOR THE ESSURE CONFIRMATION TEST BEFORE YOU CAN RELY ON ESSURE FOR BIRTH CONTROL. YOU MUST CONTINUE TO USE ANOTHER FORM OF BIRTH CONTROL TO PREVENT PREGNANCY UNTIL YOUR DOCTOR TELLS YOU THAT YOU CAN RELY ON ESSURE FOR BIRTH CONTROL.

Minimally Invasive Procedure- Essure placement requires no cutting, leaves no visible scars, and can be performed in your doctor’s office.

No General Anesthesia Required- You can remain fully conscious during the procedure. Your doctor may recommend a medication to reduce anxiety and/or use a local (numbing) anesthetic to reduce potential discomfort.

Non-Hormonal- For patients who prefer or need non-hormonal birth control, Essure inserts do not contain or release hormones.

Return to Normal Activity within 1 to 2 days- The majority of women (60%) return to normal activity within 1 day or less, and more than 75% return to normal activities within 2 days.

Short Placement Time- Total procedure time on average is 36 minutes. In the most recent clinical study, over 96% of women were able to have both inserts placed at the first placement attempt.

Highly Effective- The Essure procedure is 99.3% effective at preventing pregnancy in patients who were told to rely on Essure for birth control (based on first year reliance in the most recent clinical study).

You must continue to use another form of birth control until you have your Essure Confirmation Test and your doctor tells you that you can rely on Essure for birth control.

You are in the second half (weeks 3 and 4) of your menstrual cycle. During that time there is an increased risk of being pregnant prior to having the Essure procedure

You should speak to your doctor if:

You are taking or receiving therapy that suppresses your immune system. Examples include chemotherapy or corticosteroids, such as prednisone. Therapy that suppresses the immune system may make the Essure procedure less effective for birth control

You have, or think that you may have, a history of metal allergies or an allergy to polyester fibers, nickel, titanium, platinum, silver-tin, or stainless steel or any other components of the Essure system

You are currently using an IUD for contraception

You have already had, or are considering a procedure to reduce bleeding from the uterus (such as endometrial ablation) tell your doctor as it may affect the Essure procedure

The ablation procedure should not be performed on the same day as your Essure placement procedure

If you have Essure placed, your doctor must confirm that it is in a satisfactory location (via the Essure Confirmation Test) before performing an ablation procedure

Bayer has made a business decision to voluntarily discontinue sales and distribution of Essure in the U.S. after December 31, 2018. We made this decision based on a decline in Essure sales, and the conclusion that the Essure business is no longer sustainable. There has been no change in the positive safety and efficacy profile of Essure, and the U.S. Food & Drug Administration has maintained for several years that the benefits of Essure outweigh its risks.

Women who have chosen Essure can continue to confidently rely on the device to prevent pregnancy. It’s important to speak with your healthcare provider if you have any questions. You can also contact the Bayer Customer Care Call Center at 1-888-84-BAYER.

About the Essure procedure

Essure is a non-hormonal permanent birth control method that works with your body to create a natural barrier against pregnancy. The Essure procedure involves permanently placing a soft, flexible insert into each of your fallopian tubes. Over a period of about 3 months, a natural barrier forms around the inserts that keeps sperm from reaching the eggs and prevents conception. During the 3-month period, you must continue to use another form of birth control.

The soft, flexible, coil-shaped Essure inserts are made from polyester fibers, nickel, titanium, platinum, silver-tin and stainless steel. These same materials have been used for many years in cardiac stents and other medical devices placed in other parts of the body. The Essure inserts do not contain hormones.

Patients with known hypersensitivity to polyester fibers, nickel, titanium, platinum, silver-tin, stainless steel, and/or any of the components of the Essure insert may have an allergic reaction. This includes patients with a history of metal allergies. Some patients may develop an allergy to nickel or other components of the insert after placement. Symptoms reported in women using Essure that may be associated with an allergic reaction include hives, rash, swelling and itching. There is no reliable test to predict who may develop a reaction to the inserts.

There may be some pain associated with placing Essure. Some women report mild to moderate discomfort, pain, and cramping, during or after the placement procedure. Symptoms may be similar to what they might experience in their normal monthly cycle. There are reports of chronic pelvic pain in women, possibly related to Essure. In these cases, it may be necessary to remove the insert.

In the clinical trials, some women reported mild to moderate side effects during and after the procedure. During the procedure, the most common side effect reported was mild to moderate pain (9.3%). Some of the women in the study reported moderate pain (12.9%) and/or cramping (29.6%) on the day of the procedure. A smaller percentage of women reported nausea/vomiting (10.8%) and vaginal bleeding (6.8%). Eighty-eight percent of women rated tolerance of the placement procedure as good, very good, or excellent.

As with all procedures, there are risks and considerations associated with Essure. Pain (acute or persistent) of varying intensity and length of time may occur and continue following Essure placement. This is also more likely to occur in women with a history of pain. There are reports of an Essure insert being located in the lower abdomen and pelvis. If this occurs you cannot rely on Essure for birth control and surgery may be necessary. Ectopic pregnancies (pregnancy outside the uterus) may occur with Essure. This can be life-threatening.

Essure is covered by most health insurance providers, including Medicaid. Under the Women’s Preventative Services provision of the Affordable Care Act, Essure may be covered by insurance without co-pays, deductibles, or out-of-pocket costs. Call your health insurance company to find out if the Essure procedure and Essure Confirmation Test are covered in full.

No. Essure is a permanent birth control method and like other forms of permanent birth control, including tubal ligation and vasectomy, Essure should not be considered a reversible birth control option. It is permanent. Before choosing Essure, you should be certain that you are done having children.

Yes, you will still have a period. Some women find that their period may become slightly lighter or heavier after their procedure. These changes are often temporary. They may also be due to stopping your previous hormonal birth control, rather than the Essure procedure.

While weight gain was not studied in the clinical trials for Essure, the Essure inserts do not contain or release any hormones. Talk to your doctor for more information. However, weight changes have been reported to the FDA by women implanted with Essure. It is unknown if it is related to Essure or other causes.

The Essure Confirmation Test verifies that the inserts are in the correct location and sometimes tests whether the tubes are blocked. The Essure Confirmation Test can be a modified HSG or a transvaginal ultrasound (TVU). Your doctor will determine which Essure Confirmation Test is appropriate for you. In some cases, it may be necessary to have both tests.

During the modified HSG, a special contrast dye is injected into your uterus. The dye is visible on x-rays. This lets the doctor confirm that the inserts are properly placed and that your tubes are blocked.

During the TVU, an ultrasound device will be placed into your vagina. The ultrasound will enable your doctor to see the Essure inserts within your fallopian tubes and determine if the inserts are in the proper place. If the doctor is unable to determine if the inserts are in the proper place with the TVU, you will need to have a modified HSG.

If you have experienced unusual post-procedure pain or have undergone treatment that suppress your immune system such as chemotherapy or use of corticosteroids such as prednisone, talk to your doctor before scheduling the Essure Confirmation Test, as the TVU test is not appropriate for you.

Yes. The Essure Confirmation Test is an important and necessary step in the Essure procedure. You must continue to use another form of birth control until you have your Essure Confirmation Test and your doctor tells you that you can rely on Essure for birth control. For some women, it may take longer than 3 months for Essure to completely block the fallopian tubes, requiring a repeat Essure Confirmation Test at 6 months.

The Essure inserts can be safely scanned with MRI only under specific conditions. Before you have an MRI, tell your doctor that you have had the Essure inserts placed.

After your Essure procedure, you will be given an Essure ID card. The ID card tells doctors and others that you have Essure inserts in your fallopian tubes. Show the card before having any procedure involving your abdomen, pelvis, uterus or fallopian tube, including an MRI, D&C, hysteroscopy, endometrial biopsy, or endometrial ablation. Body areas near the inserts may be obscured when they are seen on x-rays, MRIs, and other imaging.

Tell your doctor that you have Essure inserts when discussing any other gynecologic procedures. After your Essure procedure, you will be given an Essure ID card. The ID card tells doctors and others that you have Essure inserts. Show the card before having any procedure involving your abdomen, pelvis, uterus or fallopian tube. These include an MRI, D&C, hysteroscopy, endometrial biopsy, or endometrial ablation. Body areas near the inserts may be obscured when they are seen on x-rays, MRIs, and other imaging. Tell your doctor before having any other gynecologic procedures.

Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.

Important Safety Information

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device.

Essure is not right for you if you are uncertain about ending your fertility, suspect you are pregnant, can have only one insert placed, have had your tubes tied, have a known allergy to contrast dye, are unwilling to undergo the Essure Confirmation Test, have unexplained vaginal bleeding, or have suspected or known cancer of the female reproductive organs.

You should delay having the Essure procedure if you are or have been pregnant within the past 6 weeks, have an active gynecological infection, or are in the second half of your menstrual cycle.

Tell your doctor if you are taking immunosuppressants, have, or think that you may have, a history of metal allergies, or an allergy to polyester fibers, nickel, titanium, platinum, silver-tin, or stainless steel or any other components of the Essure system, are currently using an IUD for contraception, or have had or are considering a procedure to reduce bleeding from the uterus such as endometrial ablation.

WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control.

WARNING: You must continue to use another form of birth control until you have your Essure Confirmation Test (3 months after the procedure) and your doctor tells you that you can rely on Essure for birth control. For some women, it may take longer than 3 months for Essure to be effective, requiring a repeat confirmation test at 6 months. Talk to your doctor about which method of birth control you should use during this period. If you rely on Essure for birth control before receiving confirmation from your doctor, you are at risk of getting pregnant.

During the Procedure: In the premarketing study, some women experienced mild to moderate pain (9.3%). Your doctor may be unable to place one or both Essure inserts correctly. In rare cases, part of an Essure insert may break off during placement. If breakage occurs, your doctor will remove the piece, if appropriate. There is a risk of perforation of the uterus or fallopian tube by the hysteroscope, Essure system or other instruments used during the procedure. In the original premarket studies, perforation due to the Essure insert occurred in 1.8% of women. A perforation may lead to bleeding or injury to bowel or bladder, which may require surgery. Your doctor may recommend a local anesthesia. Ask your doctor about the risks associated with this type of anesthesia.

Immediately Following the Procedure: In the premarketing study, some women experienced mild to moderate pain (12.9%) and/or cramping (29.6%), vaginal bleeding (6.8%), and pelvic or back discomfort for a few days. Some women experience headaches, nausea and/or vomiting (10.8%), or dizziness and/or fainting. You should arrange to have someone take you home after the procedure. In rare instances, an Essure insert may be expelled from the body.

During the Essure Confirmation Test: As one of the Essure Confirmation Tests (a modified HSG) requires an x-ray, you may be exposed to very low levels of radiation, as with most x-rays, if this test is used. Some women may experience nausea and/or vomiting, dizziness and/or fainting, cramping, pain or discomfort. In rare instances, women may experience spotting and/or infection

Long-term Risks: Pain (acute or persistent) of varying intensity and length of time may occur and continue following Essure placement. This is also more likely to occur in women with a history of pain. There are reports of an Essure insert being located in the lower abdomen and pelvis. If this occurs, you cannot rely on Essure for birth control. Patients with known hypersensitivity to any of the components of the Essure system may experience an allergic reaction to the insert. In addition, some patients may develop an allergy to nickel or other components of the insert following placement. Symptoms reported in women using Essure that may be associated with an allergic reaction include hives, rash, swelling and itching. There is no reliable test to predict who may develop a reaction to the inserts. No birth control method is 100% effective. Ectopic pregnancies (pregnancy outside the uterus) may occur with Essure. This can be life-threatening. If insert removal is indicated, surgery will be necessary.

The safety and effectiveness of Essure has not been established in women under 21 or over 45 years old.

Essure does not protect against HIV or other sexually transmitted diseases.

Prescription Only

Talk to your doctor about Essure and whether it is right for you. Review the Patient-Doctor Discussion Checklist in the Patient Information Booklet with your doctor before deciding to have the Essure procedure.